FDA Clears Aortic, Mitral Valve-In-Valve Procedures for Sapien 3 TAVR Valve | DAIC
`
`(/)
`
`FEATURE | HEART VALVE TECHNOLOGY (/CHANNEL/HEART-VALVE-TECHNOLOGY) | JUNE 06, 2017| DAVE
`FORNELL
`FDA Clears Aortic, Mitral Valve-In-Valve Procedures for
`Sapien 3 TAVR Valve
`
`June 6, 2017 — The U.S. Food and Drug Administration (FDA) has granted market clearance for aortic
`and mitral valve-in-valve procedures using the Edwards Lifesciences Sapien 3 transcatheter heart valve
`(THV). The Sapien 3 valve is the rst transcatheter heart valve approved in the U.S. for the treatment of
`both aortic and mitral patients who are at high risk for a subsequent open-heart surgery to replace their
`bioprosthetic valve.
`
`https://www.dicardiology.com/article/fda-clears-aortic-mitral-valve-valve-procedures-sapien-3-tavr-valve
`
`1/3
`
`Edwards Lifesciences Corporation, et al. Exhibit 1038, p. 1 of 3
`
`

`

`FDA Clears Aortic, Mitral Valve-In-Valve Procedures for Sapien 3 TAVR Valve | DAIC
`
`"This approval brings a safe and eective transcatheter therapy to patients who would do very poorly
`with repeat open-heart surgery," said John Carroll, M.D., professor of cardiology at the University of
`Colorado School of Medicine and director of interventional cardiology at the University of Colorado
`Hospital, Denver, and member of the TVT Registry Steering Committee. "I am pleased to see that the
`FDA recognizes the value of the high-quality evidence generated by the STS-ACC TVT Registry and its
`ability to play an important role in assessing 'real-world' clinical results in specialty indications, such as
`valve-in-valve, and for particular patient groups, such as those needing replacement of a bioprosthetic
`mitral valve."
`
`This anticipated FDA approval of the indication expansion was supported by real-world data collected
`from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter
`Valve Therapy (TVT) Registry. The TVT Registry includes information and outcomes on patients
`undergoing transcatheter valve replacement and repair procedures in the United States.
`
`The FDA evaluated data from the registry outcome to support the marketing application. It consisted of
`314 patients who had undergone aortic valve-in-valve procedures and 311 patients who had undergone
`mitral valve-in-valve procedures. The registry data showed that more than 85 percent of patients who
`underwent aortic or mitral valve-in-valve procedures experienced clinically meaningful improvement in
`their heart failure symptoms 30 days after the procedure, as shown by their New York Heart Association
`(NYHA) Classications. The NYHA Classication is a common classication system by which heart
`failure symptoms are rated. In both aortic and mitral valve-in-valve patients, the observed mortality rates
`were substantially lower than the expected mortality rate for repeat surgery.
`
`The FDA sent a press release for the new indication, which it usually does only for new innovations that
`may have a larger impact on healthcare.
`
`"For the rst time, a regulatory agency is approving a transcatheter heart valve as a valve-in-valve
`treatment when bioprosthetic mitral or aortic valves fail in patients who are at high or greater risk of
`complications from repeat surgery," said Bram Zuckerman, M.D., director of the division of
`cardiovascular devices at the FDA’s Center for Devices and Radiological Health. "This new approval
`oers U.S. patients with failing surgical bioprosthetic aortic or mitral valves a less-invasive treatment
`option."
`
`The FDA said Sapien 3 THV is indicated for use in patients who previously received a tissue aortic or
`mitral valve that has become narrowed, leaky or both, so blood is not able to ow eciently through the
`valve. The Sapien 3 THV was previously approved for patients whose own native aortic valves become
`narrowed by aortic stenosis. As the heart works harder to pump enough blood through the valve, it
`eventually weakens, which can lead to life-threatening heart problems such as fainting, chest pain, heart
`failure, arrhythmia or cardiac arrest.
`
`The FDA stated the Sapien 3 THV should only be used in patients who are at high or greater risk of
`death or serious complications from traditional open-heart surgery to replace the failed surgical tissue
`valve, as determined by their heart team composed of a cardiologist and surgeon.
`
`https://www.dicardiology.com/article/fda-clears-aortic-mitral-valve-valve-procedures-sapien-3-tavr-valve
`
`2/3
`
`Edwards Lifesciences Corporation, et al. Exhibit 1038, p. 2 of 3
`
`

`

`FDA Clears Aortic, Mitral Valve-In-Valve Procedures for Sapien 3 TAVR Valve | DAIC
`
`As part of the approval, the manufacturer will participate as a stakeholder of the STS/ACC Transcatheter
`Valve Therapy Registry to ensure FDA surveillance for the device over the next ve years.
`
`The Sapien 3 valve was approved by the FDA in 2015 for severe, symptomatic aortic stenosis patients at
`high risk for open-heart surgery, and, in 2016, received approval for the treatment of patients who are at
`intermediate risk for open-heart surgery. The Sapien 3 valve builds on Edwards' decades of experience in
`the development of tissue heart valves, and the proven benets of the Sapien valves.
`
`
`
`Related Content:
`
`Wow! — My Single Word Summary of TAVR Data at ACC 2016
`(https://www.dicardiology.com/content/blogs/wow-%E2%80%94-my-single-word-summary-tavr-data-
`acc-2016)
`
`Early Quality of Life Improvements Sustained for Intermediate-Risk Patients Treated with Edwards
`Transcatheter Valves (https://www.dicardiology.com/content/early-quality-life-improvements-sustained-
`intermediate-risk-patients-treated-edwards)
`
`Edwards Sapien Valves Demonstrate Excellent Durability in Five-Year Echo Study
`(https://www.dicardiology.com/content/edwards-sapien-valves-demonstrate-excellent-durability-ve-
`year-echo-study)
`
`
`
`For more information: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm561924.htm
`(https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm561924.htm)
`
`https://www.dicardiology.com/article/fda-clears-aortic-mitral-valve-valve-procedures-sapien-3-tavr-valve
`
`3/3
`
`Edwards Lifesciences Corporation, et al. Exhibit 1038, p. 3 of 3
`
`